KalVista Pharmaceuticals(KALV) - 2025 Q1 - Quarterly Results

Financial Performance - KalVista Pharmaceuticals reported no revenue for the first fiscal quarter ended July 31, 2024, consistent with the same period in the prior fiscal year[5]. - The net loss for the quarter was $40.4 million, or$(0.87) per share, compared to a net loss of $25.3 million, or$(0.74) per share, in the prior year[6]. - Total operating expenses for the quarter were $44.2 million, compared to$29.1 million in the same period last year[11]. Research and Development - Research and development expenses increased to $26.6 million for the quarter, up from$19.3 million year-over-year, primarily due to the phase 3 KONFIDENT trial and increased personnel costs[5]. - The KONFIDENT-KID pediatric clinical trial has been initiated, enrolling approximately 24 children aged 2 to 11 years across seven countries[3]. Administrative Expenses - General and administrative expenses rose to $17.6 million, compared to$9.8 million in the same quarter last year, driven by higher commercial planning and employee-related expenses[5]. Cash Position - Cash, cash equivalents, and marketable securities decreased to $174.3 million as of July 31, 2024, down from$210.4 million on April 30, 2024, due to cash consumption from operating expenses[6]. Regulatory Developments - The FDA accepted the NDA for sebetralstat with a PDUFA goal date of June 17, 2025, and the EMA validated the MAA submission[2]. - KalVista plans to file for approval in the UK, Japan, and other countries later in 2024, aiming for the first commercial launch of sebetralstat in June 2025[2]. - The company expects to maximize regulatory collaboration across countries through engagement with the Access Consortium[3].